A pharmaceutical manufacturer was working with Fisher Clinical Services in support of multiple clinical trials and protocols. Patients enrolled in these trials were occasionally unable to maintain an appointment at their respective investigator site. The circumstances were many and varied. Examples included:

  • A hurricane had impacted all travel to one of the locations dispensing the medication.
  • A patient had moved to another state in southwest United States. Although approved to receive the medication from a west coast facility, they could not travel the distance.
  • In a compassionate use scenario the patient was located in Florida but the medication was in New England.

The Sponsor recognized that providing Direct-to-Patient service on an exception basis would meet a critical need. Because the patients participating in these trials were able to self-medicate, it was strictly the residential delivery that needed to be addressed.